DMAC News & Events

DiaMedica Therapeutics announced that it has received a written response from the U.S. Food and Drug Administration, FDA, regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 for the treatment of preeclampsia. DiaMedica believes, based on the FDA's feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug, IND, application, provided that DiaMedica can demonstrate sufficient evidence of DM199 exposure and enzymatic activity throughout the previous completed rat study, as well as adequate pharmacologic effect in rats to support their use as an appropriate toxicology species. To address the FDA's request, DiaMedica is initiating a pharmacokinetic and pharmacologic activity study of DM199 in rats and is summarizing the recently completed study data intended to support the pharmacodynamic activity of DM199 in this species. Upon completion of the rat PK study, DiaMedica plans to submit the requested information to FDA for review.

DiaMedica Therapeutics announced that enrollment in its pivotal Phase 2/3 ReMEDy2 trial of DM199in patients with acute ischemic stroke, AIS, has reached 75% of the 200-patient threshold required to trigger the planned interim analysis. The Company reiterates its guidance regarding completion of the interim analysis by the end of 2026.

"We continue to focus on moving our clinical programs forward. Looking ahead, we anticipate four separate preeclampsia data readouts and a readout from our fetal growth restriction trial between now and the end of 2027. Collectively, these datasets are anticipated to inform dose selection for a potential multi-national Phase 3 program in early-onset preeclampsia. We will also weigh the risks and advantages of providing interim updates as clinically meaningful data emerges ahead of formal readouts," stated Rick Pauls, President and Chief Executive Officer of DiaMedica Therapeutics. "In acute ischemic stroke, ReMEDy2 has surpassed 70% of the required enrollment for, and we are now focused on completing, the interim analysis in the fourth quarter of 2026, which will determine the final number of participants required to complete the study."

DiaMedica sees cash, equivalents funding operations through 2027